Method of manufacturing a medical device for external application to the head of a patient

ABSTRACT

A method of manufacturing a custom device for external application to the head of a patient over a removed portion of the cranium of the patient is described. A three dimensional digital image portion of the external surface of the head comprising at least the removed portion is generated. A three dimensional digital image portion is processed to identify the removed portion. A digital file is generated that is utilized to manufacture the device.

RELATED APPLICATIONS

This application is a division of copending U.S. patent application Ser.No. 14/588,282, filed Dec. 31, 2014.

FIELD OF THE INVENTION

The present invention relates to methods for manufacture of medicaldevices, in general, and to a method for manufacture of medical devicesfor external application to the head of a patient, in particular.

BACKGROUND

Many medical conditions related to the head of a patient may be treatedby the use of medical devices that are externally applied to the head ofthe patient.

One set of medical conditions, e.g., trauma, tumor, disease, are knownto cause the brain to swell, increasing intracranial pressure (ICP). Inmany situations this increase in ICP may be life threatening, requiringa surgical procedure known as a decompressive craniotomy. In thisprocedure, a large segment of cranial bone, known as the bone flap, isremoved from the cranium. The removal of the bone flap relieves theintracranial pressure by allowing the brain to temporarily swell throughthe hole made in the cranium.

The bone flap is stored, with the intent of returning it to the cranium,once the swelling has subsided and the patient has stabilized, typically4-6 weeks after the procedure. The bone flap is stored either bysurgically inserting it into the abdomen, or by freezing it. Until thebone flap is replaced, it may be desirable to protect the portion of thehead comprising the portion where the bone flap has been removed.

One option is to provide a external plate that is affixed to the scalpof the patient as described in a copending patent application Serial No.filed on even date herewith and assigned to a common assignee. Thecontents of that application are incorporated herein by reference.

Accordingly, it is desirable to provide a method of manufacturing amedical device for external application to the head of a subject.

SUMMARY

In accordance with the principles of the invention, a plurality ofstereographic digital image pairs of at least a portion of a head thatis of interest is captured. The image pairs are processed to generate athree dimensional digital image and data file of at least of the portionof interest. The data file is utilized a device for affixation to thehead of a patient.

One embodiment of a method of manufacturing a custom device for externalapplication to the head of a patient over a removed portion of thecranium of the patient, comprises: generating a three dimensionaldigital image portion of the external surface of the head comprising atleast the removed portion; processing the three dimensional digitalimage portion to identify the removed portion as a three dimensionalremoved portion digital image file; and processing the three dimensionalremoved portion digital image file to determine one or more of a size,shape, contour and alignment for the custom device and to generate adevice data file.

An embodiment of a method of manufacturing a device for externalapplication to the scalp of a patient over a removed portion of thecranium of the patient, comprises: providing a three dimensional digitalimage portion of the head of the patient comprising at least a portionof the head comprising the removed portion; processing the threedimensional digital image portion to identify at least the removedportion as a three dimensional removed portion image file; processingthe three dimensional removed portion image file to determine one ormore of a size, shape, contour and alignment for the cranial plate; andgenerating a device file from the processing step.

One embodiment of a method of manufacturing a cranial plate for externalapplication to the scalp of a patient over a removed portion of thecranium of the patient, comprising: providing a three dimensionaldigital image portion of the head of the patient comprising at least aportion of the head comprising the removed portion; processing the threedimensional digital image portion to identify at least the removedportion; generating a shape for the cranial plate from the threedimensional digital image portion such that the cranial plate comprisesa convex portion and extends over the scalp for a predetermined distancebeyond the removed portion; and utilizing the shape to generate a datafile utilizable to manufacture the cranial plate.

Another embodiment of a method of manufacturing a cranial plate forexternal application to the scalp of a patient over a removed portion ofthe cranium of the patient, comprises: providing a three dimensionaldigital image portion of the head of the patient comprising at least aportion the removed portion; processing the three dimensional removedportion image file to determine one or more of a size, shape, contourand alignment for the cranial plate; generating a cranial plate datafile from the processing step; and utilizing the cranial plate data fileto produce the cranial plate by one of an additive machining process, asubtractive machining process, and a combination of additive machiningand subtractive machining.

An embodiment of a method of manufacturing a custom device for externalapplication to the head of a subject, comprises: providing apparatus tocapture a plurality of digital images of a plurality of portions of theexternal surface of the head; and processing the plurality of digitalimages to generate a three dimensional digital image and data file of atleast a portion of the head comprising an area of the surface of thehead to which the custom device is to be applied; and utilizing the datafile to fabricate the custom device.

An embodiment of a method of manufacturing a device for externalapplication to the head of a subject, comprises: providing stereographicdigital camera apparatus to capture stereographic digital image pairs;utilizing the stereographic digital camera apparatus to capture aplurality of stereographic digital image pairs of a plurality ofportions of the surface of the head; and processing the plurality ofstereographic digital image pairs to generate a three dimensionaldigital image and a data file of at least a portion of the headcomprising an area of the surface of the head to which the custom deviceis to be applied.

An embodiment of a method of manufacturing a custom cranial plate forexternal application to the scalp of a patient over a removed portion ofthe cranium of the patient, comprises: providing apparatus comprising aplurality of image capturing devices each arranged to capture acorresponding image of a corresponding surface portion of the head;simultaneously operating the plurality of image capturing devices tosimultaneously capture a plurality of images of the head; processing theplurality of images to produce a three dimensional digital image of thehead; identifying the removed portion on the three dimensional digitalimage of the head; selecting a three dimensional digital image portionextending over the scalp for a predetermined distance beyond the removedportion; and utilizing the selected three dimensional digital imageportion to generate a data file utilizable to manufacture the customcranial plate.

Another embodiment of a method of manufacturing a custom cranial platefor external application to the scalp of a patient over a removedportion of the cranium of the patient, comprises: providing a pluralityof stereographic digital cameras each operable to capture acorresponding pair of stereographic images; positioning the plurality ofstereographic digital cameras to simultaneously capture a correspondingplurality of stereographic digital image pairs of at least acorresponding vertical hemispherical portion of the head when thepatient is positioned in a predetermined location with respect to theplurality of stereographic digital cameras; simultaneously operating theplurality of stereographic digital cameras to simultaneously capture aplurality of stereographic digital image pairs of the head; processingthe plurality of stereographic digital image pairs to produce a threedimensional digital image of the head; identifying the removed portionon the three dimensional digital image of the head; selecting a threedimensional digital image portion extending over the scalp for apredetermined distance beyond the removed portion; and utilizing theselected three dimensional digital image portion to generate a data fileutilizable to manufacture the custom cranial plate.

An embodiment of a method of manufacturing a custom cranial plate forexternal application to the scalp of a patient over a removed portion ofthe cranium of the patient, comprises: providing a stereographic digitalcamera operable to capture a corresponding pair of stereographic images;positioning the stereographic digital camera at a plurality of locationsrelative to the head to capture a plurality of stereographic digitalimage pairs of the head; operating the plurality of stereographicdigital cameras in each of the positions to capture a plurality ofstereographic digital image pairs of at least that portion of the headcomprising the removed portion; processing the plurality ofstereographic digital image pairs to produce a three dimensional digitalimage of the at least that portion of the head comprising the removedportion; selecting a three dimensional digital image portion extendingover the scalp for a predetermined distance beyond the removed portion;and utilizing the selected three dimensional digital image portion togenerate a data file utilizable to manufacture the custom cranial plate.

Another embodiment of a method of manufacturing a cranial plate forexternal application to the scalp of a patient over a removed portion ofthe cranium of the patient, comprises: providing a three dimensionaldigital image portion of the head of the patient comprising at least aportion of the head comprising the removed portion; processing the threedimensional digital image portion to identify the removed portion as athree dimensional removed portion image file processing the threedimensional removed portion image file to determine one or more of asize, shape, contour and alignment for the cranial plate; generating acranial plate data file from the processing step; and utilizing thecranial plate data file to produce at least a portion of the cranialplate by thermoplastic forming.

An embodiment of a method for use with a subject having a removedcranium portion, comprises: providing a three dimensional digital imageportion of the head of the subject comprising the removed portion, thethree dimensional digital image portion produced from a plurality ofdigital images produced by one of a stereographic digital image camera,a plurality of stereographic digital image cameras, and a plurality ofpairs of digital image cameras; and processing the three dimensionaldigital image portion to determine one or more of an initial cranialvolume loss for the patient and a volume filling secondary toapplication of a cranial plate device fitted to the patient.

BRIEF DESCRIPTION OF THE DRAWING

The invention will be better understood from a reading of the followingdetailed description in conjunction with the drawing figures in whichlike reference designators are utilized to identify like element, and inwhich:

FIG. 1 is a model of a cranium with a removed portion;

FIG. 2 shows the model of FIG. 1 with a external cranial plate;

FIG. 3 is a top view of an embodiment of a external cranial plate;

FIG. 4 is a side view of the embodiment of FIG. 3;

FIG. 5 is a cross-section of the embodiment of FIG. 3 taken along line5-5;

FIG. 6 is a top view of a second embodiment of a external cranial plate;

FIG. 7 is a side view of the embodiment of FIG. 6.

FIG. 8 is a cross-section of the embodiment of FIG. 6 taken along line8-8 of FIG. 7

FIG. 9 is a block diagram of a system;

FIG. 10 illustrates steps in a first method;

FIG. 11 illustrates steps in a second method;

FIG. 12 illustrates steps in a third method;

FIG. 13 illustrates steps in a fourth method;

FIG. 14 illustrates steps in a sixth method;

FIG. 15 illustrates steps in a seventh method;

FIG. 16 illustrates steps in a eighth method;

FIG. 17 illustrates steps in a ninth method; and

FIG. 18, which is on the same drawing sheet as FIG. 14, illustratessteps in a fifth method;

DETAILED DESCRIPTION

U.S. Pat. No. 7,127,101 issued Oct. 24, 2006; U.S. Pat. No. 7,142,701issued Nov. 28, 2006; U.S. Pat. No. 7,162,075 issued Jan. 9, 2007; U.S.Pat. No. 7,177,461 issued Feb. 13, 2007; U.S. Pat. No. 7,227,979 issuedJun. 5, 2007; U.S. Pat. No. 7,242,798 issued Jul. 10, 2007; U.S. Pat.No. 7,245,743 issued Jul. 17, 2007; U.S. Pat. No. 7,280,682 issued Oct.9, 2007; U.S. Pat. No. 7,305,369 issued Dec. 4, 2007; U.S. Pat. No.7,542,950 issued Jun. 2, 2009; U.S. Pat. No. 8,103,088 issued Jan. 24,2012; U.S. Pat. No. 8,217,993 issued Jul. 10, 2012; U.S. Pat. No.8,442,288 issued May 14, 2013; U.S. Pat. No. 8,442,308 issued May 14,2013; U.S. Pat. No. 8,472,681 issued Jun. 25, 2013; and U.S. Pat. No.8,494,237 issued Jul. 23, 2013 are all assigned to the assignee of thepresent application and the disclosures contained in each of the patentsare expressly incorporated herein by reference.

As used herein a “stereographic” or “three-dimensional” digital camerais used to describe a digital camera that is configured to acquire aplurality of two-dimensional digital images with identical magnificationof a scene at different vantage points without relocating the camera todifferent locations. The stereographic digital camera may simultaneouslyor sequentially at a high rate of speed record each of a plurality oftwo-dimensional digital images. Various stereographic digital camerasare known in the prior art as are three-dimensional lens attachments todigital cameras that convert the two-dimensional digital camera into astereographic digital camera. In one specific embodiment of theinvention a conventional single lens reflex (SLR) digital camera isutilized with removable lens capability provided with a 3D lens,referred to by some suppliers as a “stereo lens”. In that embodiment,the digital camera captures two two-dimensional images simultaneously.

After capturing the plurality of two-dimensional images, thestereographic digital camera may either store the resulting digitalimages onto a memory card or it may transmit the digital images to aprocessor either via cabling or via a wireless link or via a combinationof one or more wireless links and a wired or cable link.

In certain embodiments, the processor and display are located inproximity to the stereographic digital camera. However, in otherembodiments, either the processor or the processor and the display areremotely located from the stereographic digital camera.

As used herein, the term “stereographic digital images” refers to a pairof digital images captured simultaneously or sequentially at a high rateof speed, with each digital image being captured from a differentvantage or view point.

Turning now to FIG. 1, a model 100 is shown of a head. Model 100simulates the head of a patient that has had a decompressive craniotomy.The outer surface 101 of model 100 represents the scalp or skin coveringthe head. Model 100 includes a concave portion 103 that isrepresentative of the depression that results as a result of adecompressive craniotomy in which a bone flap is removed. Concaveportion 103 is bounded by edge 105. Edge 105 is representative of wherethe scalp covers the edge of the cranial bone. Line 107, whichcompletely encircles concave portion 103, represents the perimeter of acustom manufactured external plate 200 shown in FIG. 2. Line 107 isspaced outward from concave portion 103 by a distance 109 forming acircumferential or peripheral scalp portion 111 that surrounds concaveportion 103.

In FIG. 2, external cranial plate 200 is in place on model 100. Externalcranial plate 200 is comprises a hard material. In the embodiment shown,cranial plate 200 comprises a polycarbonate material that is opticallytransparent thereby permitting observation of concave portion 103.external cranial plate 200 fully covers concave portion 103 and extendsbeyond edge 105 to line 107 along its entire periphery 201 providing aperipheral edge portion 203.

A bio-adhesive is utilized to removably affix peripheral edge portion203 to the scalp in peripheral scalp portion 111. The bio-adhesive isapplied along the entire peripheral edge portion 203. By utilizing abio-adhesive, external cranial plate 200 is sealed in airtight andwatertight engagement to peripheral scalp portion 111 covering the boneflap region or concave portion 103. The bio-adhesive utilized is one ofa type commonly used with osteotomy products and can be used on skin foryears with excellent tolerance.

FIGS. 3, 4 and 5 show an embodiment of external cranial plate 200. Theside view in FIG. 3 and cross-section view of FIG. 5 clearly show thatexternal cranial plate 200 is generally convex and its peripheral edgeportion 203 is shaped to mate with the peripheral scalp portion 111.

Another embodiment of a external cranial plate 600 is shown in FIGS. 6,7, and 8. external cranial plate 600 has at least one port 601 formedtherein. Port 601 comprises a through aperture 603. Through aperture 603may have a valve 605 coupled therein. Valve 605 may be utilized toreduce the pressure under external cranial plate 200. Reducing thepressure under external cranial plate 200 to less than atmosphericpressure helps adhere external cranial plate 200 to the scalp. Inaddition reducing the pressure helps prevent cranial collapse and mayalso allow for rehydration of the brain.

Port 601 may also have a transducer or sensor carried therein. Thetransducer or sensor may be any transducer or sensor of medical interestsuch as, e.g., a pressure sensor or humidity sensor.

Turning now to FIG. 9, system 900 is utilized to manufacture the devicedescribed herein. System 900 comprises digital image capture apparatus901. Digital image capture apparatus 900 is utilized to capture aplurality of three dimensional digital image pairs of a surface of asubject.

The three dimensional digital image pairs are provided to processor 903.The three dimensional digital image pairs are stored in data memory 905.Program memory 907 comprising various programs for processing threedimensional digital image pairs. A data file memory 909 stores processedthree dimensional digital surface image pairs. A database 911 isutilized to store a library of processed three dimensional digital imagedata files. It will be appreciated by those skilled in the art thatalthough data memory 905, program memory 907, data file memory 909 anddata base 911, although shown as separate memories in FIG. 9, maycomprise portions of one or more physical memories.

Associated with processor 903 is an input output interface 913.Input/output interface 13 comprises a display 915 and an input interface917. Display 915 may be any one of a number of conventional displays,and input interface 917 may be any one or more of a number ofconventional input apparatus. Display 915 may be a “touch screen” havingan integrated input interface.

Processor 903, utilizing a program from program memory 907 is utilizedto process each digital surface image pair to generate a threedimensional digital image surface portion of a subject's head. Display915 may be utilized to display three dimensional digital image surfaceportions produced from each three dimensional digital image pair. Eachsurface is a surface portion image of a subject's head captured from adifferent vantage point. The corresponding data file for each threedimensional digital image surface portion is stored in data memory 905.

Each digital surface image portion is cleaned by removing extraneousdata. The cleaning operation may be done via selection of extraneousportions by a system operator viewing each three dimensional digitalimage surface portion on display 915 and utilizing input apparatus 913to select the data portion to be deleted by processor 903. In otherembodiments, processor 903 may be programmed to either automaticallydelete extraneous portions or may be operated semi-automatically incombination with manual selection by a system operator.

Each three dimensional digital image surface portion is cropped suchthat only the portion of the head that is of interest is retained.

Each cleaned and cropped three dimensional digital image surface portionis then aligned and registered.

In alternate embodiments best-fit algorithms may be utilized to provideregistration and alignment.

After all the digital surface image portions are registered and alignedthe digital surface image portions are stitched or fused together toform a single three dimensional surface image of the entire surface ofthe subject's head or at least that portion of the head that is ofinterest. The resulting data file of the single three dimensionaldigital surface image is stored in data file 909 and may also be storedin data base 911.

In other embodiments different alignment and registration techniques maybe employed including surface matching least squared, registration byidentification and selection of key landmarks, or other mathematicalapproaches.

The portion of the head that comprises the portion of interest isidentified. In one embodiment, the identification of the portion ofinterest is accomplished from a display of the portion of the head thatis of interest and identification of that portion by a system operatorand selecting that portion of the three dimensional surface image andits corresponding data file 909 for manufacture of a device or cranialplate.

System 900 may then be utilized to manufacture the device or cranialplate. More specifically, system 900 may further include manufacturingapparatus operable to utilize data file 909 to manufacture the device orcranial plate.

System 900 comprises a three dimensional printer 919. System 900provides data file 909 to three dimensional printer 919. Threedimensional printer 919 utilizes data file 909 to print the device orcranial plate in plastic material.

The steps for one embodiment of a method of manufacturing a customdevice for external application to the head of a patient over a removedportion of the cranium of the patient is shown in FIG. 10. At step 1001stereographic digital image pairs are captured for the head of a subjectby digital image pair capture apparatus 901 shown in FIG. 1. At step1003, a three dimensional digital image of the surface of the head isgenerated from the stereographic digital image pairs. At step 1005, aportion of interest of the external surface of the head is identified.Where the custom device is a cranial plate, the portion of interestcomprises at least the removed cranial portion and a portion extendingaround the periphery of the removed cranial portion. At step 1007,processor 903 determines one or more of a size, shape, contour andalignment for the custom device and generates a device data file. Atstep 1009, processor 903 transmits the data file to manufacturingapparatus such as three dimensional printer 919. At step 1011, threedimensional printer 919 utilizes the data file received from processor903 to fabricate the custom device. At step 1013, the custom device isfabricated to include one or more ports. The formation of the ports maybe done as part of the device fabrication step or may be a separate stepin which the ports are drilled into the custom device. At step 1015, oneor more of a valve, sensor, or transducer is provided in the one or moreports.

Another embodiment of the invention directed to a method ofmanufacturing a device for external application to the scalp of apatient over a removed portion of the cranium of the patient is shown inFIG. 11. At step 1101, a three dimensional digital image portion of thehead of the patient comprising at the removed portion is provided toprocessor 903. At step 1103, processor 903 is utilized to process thethree dimensional digital image portion to identify at least the removedportion as a three dimensional removed portion digital image file. Atstep 1105, processor 903 selects the three dimensional removed portiondigital image file to include a peripheral portion such that the devicewill engage the scalp in fluid tight and airtight engagement. At step1107, processor 903 determines one or more of the size, shape, contour,and alignment of the device. At step 1109, processor 903 shapes thedevice to comprise at least a portion that is of convex shape. At step1111, processor 903 generates a device data file. At step 1113,processor 903 transmits the device data file to three dimensionalprinter 919 and three dimensional printer 919 is utilized to fabricateat least a portion of the device. In various embodiments, the device maybe fabricated from a plurality of pieces or portions, at least oneportion is fabricated from a transparent material as indicated at step1115. At step 1117, the device is provided with at least one port and atstep 1119, the at least one port is provided with one of a valve, asensor, and a transducer.

FIG. 12 illustrates the steps in another embodiment of a method formanufacturing a cranial plate. At step 1201, processor 903 is providedwith a three dimensional digital image portion of a patient's head. Thethree dimensional digital image portion comprises at least that portionof the head including the removed cranium. At step 1203, processor 903processes the three dimensional digital image portion to determine oneor more of a size, shape, contour and alignment for the cranial plate.At step 1205, processor 903 generates a cranial plate data file, and atstep 1207 the cranial plate data file is utilized to produce a cranialplate by one of an additive machining or fabrication process, asubtractive machining process, and a combination of an additivemachining or fabrication process and subtractive machining orfabrication process.

FIG. 13 illustrates a method in which at step 1301, digital imagecapture apparatus 901 is provided to capture a plurality of digitalimages of a plurality of portions of the external surface of a head. Atstep 1303 processor 903 provides processing of the plurality of digitalimages to generate a three dimensional digital image and data file of atleast a portion of the head comprising an area of the surface of thehead to which a custom device is to be applied. At step 1305, system 900utilizes the data file to fabricate the custom device.

In FIG. 14, a method for manufacturing a custom device is described. Atstep 1401, stereographic digital camera apparatus is provided to capturestereographic digital image pairs. At step 1403 the stereographicdigital camera apparatus is utilized to capture a plurality ofstereographic digital image pairs of a plurality of portions of thesurface of the head. At step 1405, system 300 processes the plurality ofstereographic digital image pairs to generate a three dimensionaldigital image and a data file of at least the portion of the headcomprising the area of the surface to which the custom device is to beapplied.

In FIG. 15 an embodiment of a method of manufacturing a custom cranialplate for external application to the scalp of a patient over a removedportion of the cranium of the patient is shown. At step 1501, apparatus901 is provided comprising a plurality of image capturing devices eacharranged to capture a corresponding image of a corresponding surfaceportion of the head. At step 1503 the plurality of image capturingdevices are operated to simultaneously capture a plurality of images ofthe head. At step 1505, processor 903 processes the plurality of imagesto produce a three dimensional digital image of the head. At step 1507,processor 903 is utilized to identify the removed portion on the threedimensional digital image of the head. At step 1509, processor 903 isutilized to select a three dimensional digital image portion extendingover the scalp for a predetermined distance beyond the removed portion.At step 1511, system 300 utilizes the selected three dimensional digitalimage portion to generate a data file utilizable to manufacture thecustom cranial plate.

FIG. 16 illustrates a method of manufacturing a custom cranial plate forexternal application to the scalp of a patient over a removed portion ofthe cranium of the patient. At step 1601 a plurality of stereographicdigital cameras each operable to capture a corresponding pair ofstereographic images is provided. The plurality of stereographic digitalcameras is represented in FIG. 9 by digital image capture apparatus 901.At step 1603, the plurality of stereographic digital cameras arepositioned to simultaneously capture a corresponding plurality ofstereographic digital image pairs of at least a corresponding verticalhemispherical portion of the head when the patient is positioned in apredetermined location with respect to the plurality of stereographicdigital cameras. At step 1605, the plurality of stereographic digitalcameras are operated simultaneously to simultaneously capture aplurality of stereographic digital image pairs of the head. At step1607, processor 903 processes the plurality of stereographic digitalimage pairs to produce a three dimensional digital image of the head. Atstep 1609, processor 903 is utilized to identify the removed portion onthe three dimensional digital image of the head. At step 1611, processor903 is utilized to select a three dimensional digital image portionextending over the scalp for a predetermined distance beyond the removedportion. At step 1613, system 900 utilizes the selected threedimensional digital image portion to generate a data file utilizable tomanufacture the custom cranial plate.

FIG. 17 illustrates a method of manufacturing a custom cranial plate forexternal application to the scalp of a patient over a removed portion ofthe cranium of the patient. At step 1701 a stereographic digital cameraoperable to capture a corresponding pair of stereographic images isprovided. The stereographic digital camera is represented in FIG. 9 bydigital image capture apparatus 901. At step 1703, the stereographicdigital camera is positioned at a plurality of locations relative to thehead to thereby capture a plurality of stereographic digital image pairsof the head. At step 1705, the stereographic digital camera is operatedin each of the positions to capture a plurality of stereographic digitalimage pairs of at least that portion of the head comprising the removedportion. At step 1707, system 300 processes the plurality ofstereographic digital image pairs to produce a three dimensional digitalimage of the at least that portion of the head comprising the removedportion. At step 1709, a three dimensional digital image portionextending over the scalp for a predetermined distance beyond the removedportion is selected utilizing processor 903. At step 1711, processor 903utilizes the selected three dimensional digital image portion togenerate a data file utilizable to manufacture the custom cranial plate.

In various embodiments, a method for use with a subject having a removedcranium portion is shown in FIG. 18. At step 1801, a three dimensionaldigital image portion of the head of the subject comprising the removedportion is provided. The three dimensional digital image portion isproduced from a plurality of digital images produced by one of astereographic digital image camera, a plurality of stereographic digitalimage cameras, and a plurality of pairs of digital image cameras. Atstep 1803, the three dimensional digital image portion is processed bysystem 300 to determine one or more of an initial cranial volume lossfor the patient and a volume filling secondary to application of acranial plate device fitted to the patient.

It will be appreciated by those skilled in the art that although theembodiment shown utilizes a three dimensional printer, othermanufacturing apparatus may be utilized, including, but not limited to,subtractive type machining or fabrication apparatus.

It will be further understood by those skilled in the art that variouschanges and modifications may be made to the method and apparatus of theinvention without departing from its spirit or scope. It is intendedthat the invention not be limited to the embodiments shown and describedherein, but that the invention be given the broadest possible scopepermissible by law and that the invention is to be limited in scope onlyby the claims appended hereto.

The invention claimed is:
 1. A method of manufacturing a customprotective device configured to be removably and externally affixed to aperipheral scalp portion of a patient's head, said peripheral scalpportion overlying a depressed portion of said patient's head where aportion of the cranium of said patient has been removed, and saidperipheral scalp portion defined by a portion of said scalp extendingoutward about the entire periphery of said depressed portion by apredetermined distance on said scalp surrounding said depressed portion,the method comprising: providing an apparatus to capture a plurality ofdigital images of a plurality of portions of the external surface ofsaid head; processing said plurality of digital images to generate athree dimensional digital image of the external surface of said scalp ofsaid patient's head, said three dimensional image representing at leastsaid peripheral scalp portion and said depressed portion; processingsaid three dimensional digital image to identify said peripheral scalpportion and said depressed portion represented by said three dimensionaldigital image; generating a three dimensional digital image file of saididentified peripheral scalp portion and depressed portion; processingsaid three dimensional digital image file to determine one or more of asize, a shape, a contour, and a positional alignment for said customdevice with respect to said patient's head; generating a device datafile from said processed three dimensional digital image file; andutilizing said device data file to fabricate said custom device for saidpatient, said custom device further configured to cover said peripheralscalp portion and said depressed portion upon said affixing until saidremoved cranium portion is replaced.
 2. A method in accordance withclaim 1, wherein: said processing of said three dimensional digitalimage file is conducted such that said custom device is furtherconfigured to engage said peripheral scalp portion in a fluid tight andairtight engagement.
 3. A method in accordance with claim 1, wherein: atleast a portion of said custom device is formed from a transparentmaterial.
 4. A method in accordance with claim 1, further comprising:providing said custom device with at least one port.
 5. A method inaccordance with claim 4, further comprising: providing said at least oneport with one of a valve, a sensor, and a transducer.
 6. A method inaccordance with claim 1, wherein: said fabricating is conducted by athree dimensional printer using said device data file.
 7. A method inaccordance with claim 1, further comprising: providing said apparatus asa stereographic digital camera apparatus; and operating saidstereographic digital camera apparatus to capture a plurality ofstereographic digital image pairs of a plurality of portions of theexternal surface of said head as said plurality of digital images,wherein said processing of said plurality of digital images comprisesprocessing said stereographic digital image pairs to generate said threedimensional digital image.
 8. A method in accordance with claim 1,wherein: said custom protective device is configured to protect theintracranial contents of said patient from atmospheric pressure.
 9. Amethod in accordance with claim 1, wherein: at least a portion of saidcustom protective device comprises a convex shape.
 10. A method inaccordance with claim 1, further comprising: providing said apparatus asa plurality of image capturing devices each arranged to capture acorresponding one of said digital images of a corresponding surfaceportion of said head; and operating said plurality of image capturingdevices to simultaneously capture said plurality of digital images. 11.A method in accordance with claim 1, further comprising: providing saidapparatus as a plurality of stereographic digital cameras; positioningsaid plurality of stereographic digital cameras in a manner capable ofsimultaneously capturing a corresponding plurality of stereographicdigital image pairs of at least a corresponding vertical hemisphericalportion of said head with said patient positioned in a predeterminedlocation with respect to said plurality of stereographic digitalcameras; and simultaneously operating said plurality of stereographicdigital cameras to simultaneously capture the plurality of stereographicdigital image pairs of said head as said plurality of digital images.12. A method in accordance with claim 1, further comprising: providingsaid apparatus as a stereographic digital camera; positioning saidstereographic digital camera at a plurality of locations relative tosaid head; and operating said stereographic digital camera in each ofsaid locations to capture a plurality of stereographic digital imagepairs of at least the portion of said head comprising said removedportion as said plurality of digital images, wherein said processing ofsaid plurality of digital images comprises processing said plurality ofstereographic digital image pairs to produce said three dimensionaldigital image.
 13. A method in accordance with claim 1, wherein: saidremoved cranium portion is a bone flap.
 14. A method in accordance withclaim 1, wherein: said custom device is a cranial plate.
 15. A method inaccordance with claim 1, wherein: said custom device comprises opticallytransparent polycarbonate permitting observation of the depressedportion therethrough after said affixing.
 16. A method in accordancewith claim 1, wherein: said fabricating is conducted by one of anadditive machining process, a subtractive machining process, and acombination of additive and subtractive machining.
 17. A method inaccordance with claim 1, wherein: said fabricating is conducted bythermoplastic forming.